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FDA Issues Recall on Medtronic Catheters, and Other Companies' Devices

by Brendon Nafziger, DOTmed News Associate Editor | September 16, 2009
FDA warns against Medtronic
catheter-pump misconnections
The FDA sent letters to physicians declaring a Class 1 recall of a kind of catheter made by Medtronic, Inc., according to a statement released Monday by the Minn.-based medical device giant.

Known as a Sutureless Connector intrathecal catheter, the device might be incorrectly labeled as compatible with the IsoMed Pump Model 8472, a drug pump Medtronic discontinued last year as part of what it calls a "planned product phase-out."

Models 8709SC, 8731SC, 8578, and 8596SC of the catheter are affected by the recall.

Even though the catheter appears to fit the pump, the connection is not secure, which can cause drugs or cerebrospinal fluid to leak out, according to the statement. The results could be fatal, and include drug overdose, tissue damage and so-called spinal headaches.

Medtronic claims it has heard of at least 10 patients who had the catheter incorrectly attached to the pump. In each case medical help was required, according to the report. One patient died two days following surgery to fix the connection, although Medtronic says it cannot be known whether the device caused the patient's death.

"Individually, these products are OK," Cindy Resman, public relations officer of Medtronic, tells DOTmed News. "The SC catheters are fine with other pumps, they just cannot be used with the IsoMed Pump."

A Recent, Separate Issue

The recall comes only days after Medtronic's announcement on Friday that the batteries on its Concerto CRT-D and Virtuoso ICD pacemakers fail sooner than expected. Although the batteries give three months' warning before going out, about 6,300 devices are believed to be affected.

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ConMed Linvatec Power Pro

The FDA and ConMed Corporation announced that there is a recall on the ConMed Linvatec Power Pro, a universal hand tool for orthopedic surgical attachments, because it can randomly cause surgical tools to act erratically, potentially causing severe patient injury or death.

The recall involves aPower Pro, Power ProMax, and MPower 1 handpieces, with the following catalog numbers: POWER PRO 5100, 5100M, 5200, 5200M, 5250, 5250M, 5300, 5300M, 5400, 5400M, 6200, 6202, 6300, 6400 and 6450. A list of serial numbers is attached to the FDA recall notice. The recall also includes cables of these universal hand tools which can use a variety of orthopedic surgical tool attachments, such as surgical saws and drills.

The FDA has classified the recall as FDA Class I, meaning the use of the device brings with it a reasonable possibility of injury or death.

ConMed stated that customers will be notified with instructions on how to contact ConMed Linvatec for a schedule to return the defective devices affected by the recall.

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Some Lifepak CR Defibrillators Recalled

On September 16, FDA notified healthcare professionals of a Class I recall of certain Lifepak CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008.

An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy, FDA says.

Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178].

Important: This report contains selected news highlights only. For important details about these actions, visit:
http://www.fda.gov/Safety/Recalls/default.htm

Joan Trombetti and Lynn Shapiro contributed to this report.